Recall Z-1519-2022— Medtronic Xomed, Inc.

Name: FDA recall Z-1519-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-29

Class I · Ongoing

Class I FDA medical device recall by Medtronic Xomed, Inc., initiated 2022-04-29. It names one FDA 510(k) clearance: K050162. Product: NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506. Reason: The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes..

Recalling firm: Medtronic Xomed, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2022-04-29
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K050162 — CONTACT EMG ROTATABLE ENDOTRACHEAL TUBEMedtronic Xomed, Inc.·cleared 2005-03-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506

Reason for recall

The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

Data sourced from openFDA. This site is unofficial and independent of the FDA.